Comparison of Two Needles (19G Flex Versus 22G Standard) for Pancreatic Solid Tumors Diagnosis

Adenocarcinoma of Head of Pancreas Clinical Trial

— EASYFLEX  

Official title:

Randomized, Comparative Study of 19G Flex Versus 22G Standard Needles for Pancreatic Solid Tumors Diagnosis.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02078232
• Other study ID #: SFED N°98
• Status: Completed
• Phase: N/A
• First received: February 26, 2014
• Last updated: April 19, 2017
• Start date: April 2013
• Est. completion date: January 23, 2017

Study information

• Verified date: November 2016
• Source: French Society of Digestive Endoscopy
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to compare the diagnostic gain between 22G standard needle vs 19G Flex needles transduodenal punctures of masses of the pancreatic head.

Description:

The negative predictive value of fine needle aspiration under ultrasound endoscopy (EUS-FNA) for the diagnosis of solid pancreatic masses is about 70 - 80 % with the 22G standard needle. Pancreatic adenocarcinoma is known to have a severe prognosis and a low rate of survival even after curative surgery. The study of pancreatic solid tumors is one the main diagnostic problem present in the investigators daily practice. In most of non operated patients, EUS-FNA is the sole possibility to confirm the diagnosis of malignancy which is required to initiate chemotherapy and/or radiotherapy. To improve the performances of the EUS-FNA, new needles are now disposable either with a cutting window design (EchoTip ProCore-COOK Medical) or flexible 19G needle (19G Expect Flex - Boston-Scientific). The goal is to obtain more tissue material with the possibility of a histologic study without increasing the risk of the puncture which is very low (complications rate < 1%). The problem concerns the lesion of the head of the pancreas requiring a trans-duodenal access for the puncture . In this position, the needle is very difficult to push out the operator channel and, in some cases, the puncture is quite impossible with stiff needles as "ProCore" or standard 19G. Thus, the interest of flexible 19G needle is to be used in difficult technical cases as transduodenal access for head pancreatic tumors, with a good safety and more efficacy than 22G needles.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 124
• Est. completion date: January 23, 2017
• Est. primary completion date: July 6, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• patient with solid tumor of pancreas who has to receive a biopsy under endoscopic ultrasound (EUS)

• patient who understands the study procedures, risks and voluntarily agrees to participate by giving written informed consent

Exclusion Criteria:

• patient who participates in an other study

• patient mentally or legally incapacitated

• patient with contraindications to the achievement of upper gastrointestinal endoscopy

• patient with haemorrhagic disease, disorder of hemostasis and coagulation (TP<60%, TCA>40sec and platelets <60000/mm3)

• patient with anticoagulant or antiaggregating treatment that could not be stopped for the endoscopic procedure

• patient with pancreatic cystic mass (fluid quota valued at more than 50% of the mass lesion on imaging)

• patient pregnant or lactating women

Related Conditions & MeSH terms

• Adenocarcinoma
• Adenocarcinoma of Head of Pancreas

Intervention

Device:
• puncture of head of pancreas
puncture of head of pancreatic solid mass with fine needle aspiration under endoscopic ultrasonographic control. randomization: puncture with either 22G needle or 19G flex needle
• puncture of head of pancreas
puncture of head of pancreatic solid mass with fine needle aspiration under endoscopic ultrasonographic control. randomization: puncture with either 22G needle or 19G flex needle

Locations

Country	Name	City	State
France	Hopital Saint Joseph	Marseille

Sponsors (1)

Lead Sponsor	Collaborator
French Society of Digestive Endoscopy

Country where clinical trial is conducted

France, 

References & Publications (11)

Adler DG, Jacobson BC, Davila RE, Hirota WK, Leighton JA, Qureshi WA, Rajan E, Zuckerman MJ, Fanelli RD, Baron TH, Faigel DO; ASGE.. ASGE guideline: complications of EUS. Gastrointest Endosc. 2005 Jan;61(1):8-12. Erratum in: Gastrointest Endosc. 2005 Mar;61(3):502. — View Citation

Al-Haddad M, Wallace MB, Woodward TA, Gross SA, Hodgens CM, Toton RD, Raimondo M. The safety of fine-needle aspiration guided by endoscopic ultrasound: a prospective study. Endoscopy. 2008 Mar;40(3):204-8. Epub 2007 Dec 4. — View Citation

Boustière C, Veitch A, Vanbiervliet G, Bulois P, Deprez P, Laquiere A, Laugier R, Lesur G, Mosler P, Nalet B, Napoleon B, Rembacken B, Ajzenberg N, Collet JP, Baron T, Dumonceau JM; European Society of Gastrointestinal Endoscopy.. Endoscopy and antiplatelet agents. European Society of Gastrointestinal Endoscopy (ESGE) Guideline. Endoscopy. 2011 May;43(5):445-61. doi: 10.1055/s-0030-1256317. Epub 2011 May 4. — View Citation

Carrara S, Arcidiacono PG, Mezzi G, Petrone MC, Boemo C, Testoni PA. Pancreatic endoscopic ultrasound-guided fine needle aspiration: complication rate and clinical course in a single centre. Dig Liver Dis. 2010 Jul;42(7):520-3. doi: 10.1016/j.dld.2009.10.002. Epub 2009 Dec 1. — View Citation

Erickson RA. EUS-guided FNA. Gastrointest Endosc. 2004 Aug;60(2):267-79. Review. — View Citation

Fayers PM, Machin D. Sample size: how many patients are necessary? Br J Cancer. 1995 Jul;72(1):1-9. Review. — View Citation

Hewitt MJ, McPhail MJ, Possamai L, Dhar A, Vlavianos P, Monahan KJ. EUS-guided FNA for diagnosis of solid pancreatic neoplasms: a meta-analysis. Gastrointest Endosc. 2012 Feb;75(2):319-31. doi: 10.1016/j.gie.2011.08.049. — View Citation

Jenssen C, Dietrich CF. Endoscopic ultrasound-guided fine-needle aspiration biopsy and trucut biopsy in gastroenterology - An overview. Best Pract Res Clin Gastroenterol. 2009;23(5):743-59. doi: 10.1016/j.bpg.2009.05.006. Review. — View Citation

Song TJ, Kim JH, Lee SS, Eum JB, Moon SH, Park DY, Seo DW, Lee SK, Jang SJ, Yun SC, Kim MH. The prospective randomized, controlled trial of endoscopic ultrasound-guided fine-needle aspiration using 22G and 19G aspiration needles for solid pancreatic or peripancreatic masses. Am J Gastroenterol. 2010 Aug;105(8):1739-45. doi: 10.1038/ajg.2010.108. Epub 2010 Mar 9. — View Citation

Standards of Practice Committee of the American Society for Gastrointestinal Endoscopy., Lichtenstein DR, Jagannath S, Baron TH, Anderson MA, Banerjee S, Dominitz JA, Fanelli RD, Gan SI, Harrison ME, Ikenberry SO, Shen B, Stewart L, Khan K, Vargo JJ. Sedation and anesthesia in GI endoscopy. Gastrointest Endosc. 2008 Nov;68(5):815-26. doi: 10.1016/j.gie.2008.09.029. — View Citation

Takemoto T, Aibe T, Fuji T, Okita K. Endoscopic ultrasonography. Clin Gastroenterol. 1986 Apr;15(2):305-19. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	accuracy of 19G Flex Expect needle in the histological diagnosis of pancreatic solid tumors of the head of pancreas	accuracy and diagnostic gain of fine needle aspiration under ultrasound endoscopy (EUS-FNA) for the diagnosis of solid pancreatic tumors of the head of pancreas: comparison between 19G Flex and 22G standard needles punctures.	10 days
Secondary	morbidity	immediate per-procedure complications and delayed morbidity (up to day 30) side effects resulting of technical failure or dysfunction of the puncture ease of handling for the two needles (visual analogic scale)	2 minutes, up to day 30
Secondary	quality of histology	quality of histological specimens obtained with the 2 types of needles (visual analogic scale)	10 days